Orthofeet Shoes for Foot Pain

Overseen By Maria Noun, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bijan Najafi, PhD

Disqualifiers: Foot deformity, Amputation, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of shoe called Orthofeet to determine if it can reduce foot pain and increase physical activity. Participants will wear these shoes for six weeks and then switch to their own shoes, or vice versa, to compare effects. It targets individuals aged 50 and older who experience foot pain, such as in the heel or arch. The goal is to discover if these shoes can make daily activities more comfortable and active. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience potential benefits.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have unstable conditions with anticipated changes in your medication, you may not be eligible to participate.

What prior data suggests that Orthofeet shoes are safe for reducing foot pain?

Research shows that Orthofeet shoes prioritize comfort and safety. They feature a roomy toe area, soft padding, and special support to help prevent foot pain, making them comfortable for most people. Although these features emphasize comfort, specific studies have not mentioned any risks or side effects.

The trial is in its early stages and aims to gather more safety information. However, Orthofeet shoes are already available in stores, and their design helps reduce foot pain and improve foot health, offering reassurance about their safety for everyday use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Orthofeet shoes because they offer a unique approach to pain relief through innovative footwear design. Unlike standard treatments for foot pain, which often involve medication or orthotic inserts, Orthofeet shoes integrate advanced cushioning and ergonomic support directly into the shoe. This design aims to provide immediate and consistent pain relief with every step, potentially reducing the need for additional devices or medication. By targeting pain through enhanced footwear technology, Orthofeet presents a promising alternative for those seeking non-invasive solutions to foot pain.

What evidence suggests that Orthofeet shoes are effective for reducing foot pain?

Research has shown that Orthofeet shoes can significantly reduce foot pain and disability compared to regular shoes. In this trial, participants in Group AB will begin with a 6-week intervention using Orthofeet shoes before switching to their own shoes, while participants in Group BA will start with their own shoes and then switch to Orthofeet. People wearing Orthofeet reported being 15% more active, taking about 700 extra steps each day. Studies have also found that these shoes help burn more calories and increase overall energy use. Many people found Orthofeet easy to wear and helpful, with many willing to recommend the shoes. This suggests that Orthofeet could be a good choice for those wanting to reduce foot pain and become more active. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

You experience foot pain in your heel, arch, or ball of foot and have reported it yourself.

50 years or older

Exclusion Criteria

Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.

You have a foot ulcer and a significant foot deformity such as Charcot foot or Pes Cavus.

You have severe problems with thinking or memory, or are experiencing severe depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are involved in a 12-week randomized crossover trial wearing Orthofeet shoes and their own shoes

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orthofeet Shoes

How Is the Trial Designed?

Group I: Group AB Active Control 1 Intervention

Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes)

Group II: Group BA Active Control 1 Intervention

Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration

Who Is Running the Clinical Trial?

Bijan Najafi, PhD

Lead Sponsor

Trials

5

Recruited

280+

Orthofeet, Inc.

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

Shoe modifications and foot orthoses are effective nonsurgical treatments for various foot and ankle conditions, improving gait and increasing mobility in patients with diabetes, arthritis, and other pathologies.

Custom orthoses come in four main types, each designed to provide specific benefits such as cushioning, support, and protection, making them versatile tools for both treatment and prevention of foot-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoe modification and the use of orthoses in the treatment of foot and ankle pathology. Janisse, DJ., Janisse, E.[2019]

In a study involving 142 adults with plantar fasciitis, both prefabricated and customized foot orthoses made from low-cost EVA foam showed significant improvement in pain after 8 weeks of use, indicating their effectiveness in treatment.

There was no significant difference in pain relief between the two types of orthoses, suggesting that low-cost prefabricated EVA inserts are a viable and effective option for treating uncomplicated plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Baldassin, V., Gomes, CR., Beraldo, PS.[2022]

Using static ankle-foot orthoses (AAFOs and PAFOs) with regular shoes significantly improved balance and symmetry in stroke patients, reducing center of pressure (CoP) sway compared to just wearing shoes or being barefoot.

PAFOs were found to be more effective than AAFOs in decreasing CoP sway and enhancing weight shifting, although both types of orthoses negatively affected the natural roll-over shape of the foot during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Static ankle-foot orthosis improves static balance and gait functions in hemiplegic patients after stroke. Chern, JS., Chang, HS., Lung, CW., et al.[2020]

Citations

1.

orthofeet.com

orthofeet.com/pages/orthofeet-research-development?srsltid=AfmBOor7xjnkllOqtwL_AJe8NPVTHSjdPEM_vz8A-Z-ilaJ9cyT9w7b2

Orthofeet Research & Development

Participants wearing Orthofeet shoes showed a 15% increase in overall activity levels[3]. On average, participants took nearly 700 additional steps per day.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38776890/

Assessing the Acceptability and Effectiveness of a Novel ...

Results: Compared to participants' own shoes, OrthoFeet shoes significantly reduced foot pain and disability. Notable improvements were observed in "foot ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0268003324002055

The role of therapeutic footwear to increase daily physical ...

Wearing Orthofeet increased daily steps, calories burned, and energy expenditure in 6 weeks. Reducing foot pain with therapeutic footwear effectively enhances ...

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/78/NCT05434078/ICF_001.pdf

H-51229- ORTHOFEET: A PROSPECTIVE PROOF OF ...

The purpose of this study is to evaluate the benefits and effectiveness of the shoe ( Orthofeet) in reducing foot pain, increasing daily ...

5.

digitalcommons.library.tmc.edu

digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=1059&context=aging_research

Assessing the Acceptability and Effectiveness of a Novel ...

TAM scores favored OrthoFeet shoes over participants' own shoes in terms of ease of use, perceived benefit, and in- tention to recommend.

6.

amazon.com

amazon.com/Orthofeet-Orthopedic-Composite-Toe-Support-Cobalt/dp/B0C683FB9F

Orthofeet Men's Orthopedic Comp-Toe Cobalt Work Shoes

Orthofeet work shoes feature a wide toe-box & provide superior safety with Impact Resistance M I/75, Compression Resistance C/75, and Resistance to Electric ...

7.

orthofeet.com

orthofeet.com/collections/work-shoes?srsltid=AfmBOorXzPbLXCii0h_HWFYtkwy92mG6R5Q8IDX4bV4aYLW7Y1fqcZAz

Orthopedic Work Boots & Shoes

Orthofeet® work shoes feature a composite toe that provides robust protection against workplace hazards, ensuring your feet stay safe throughout the day. Are ...

8.

orthofeet.com

orthofeet.com/products/dolomite?srsltid=AfmBOoo-p00c41Af8ZqvyoxZFCB1lJmhu88pMxRjvYF6n1n33gmSpF_L

Dolomite Work Shoes

Stay pain-free with these safety-rated work shoes. Featuring Ortho-Cushion support, padded interior, extra depth, roomy toe box, waterproof leather, ...

9.

lehighsafetyshoes.com

lehighsafetyshoes.com/collections/orthofeet

OrthoFeet

OrthoFeet employs biomedical engineers to build innovative footwear products, designed to alleviate the symptoms associated with various foot conditions.

10.

orthofeet.com

orthofeet.com/pages/help-center?srsltid=AfmBOoqxKHgdGw0iKeCK6b2hvCER2SYVtXnEy1A6ZjpRZzeyMWCWhWq_

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